Quality Systems Analyst II

Abbott

2d • Onsite

About The Position

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution. Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

This position works out of our Alameda, CA location in the Diabetes Care division where we are focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. The Quality Systems Analyst II will be responsible for owning complaint trend escalation investigations, ensuring that potential product and process issues are thoroughly assessed and effectively managed. This includes applying structured root cause analysis (RCA) methodologies such as 5 Whys, Fishbone diagrams, and 6M frameworks with cross-functional partners to identify underlying drivers, validate findings, reach well-supported conclusions for investigations, and implement impactful changes to process and design. This position will be based out of our Abbott Diabetes Care in Alameda, CA and the individual will be expected to be onsite Monday-Friday.

Requirements

• Bachelor’s degree required.
• Minimum 3 years of experience in a manufacturing environment; medical device industry experience preferred.
• Experience conducting investigations in a regulated environment, including CAPA.
• Knowledge of FDA Quality System Regulations (QSR) and ISO 13485 standards.

Nice To Haves

• Strong ability to manage multiple tasks and priorities in a fast-paced, changing environment.
• Advanced proficiency with Microsoft Office; experience with SQL is a plus.
• Strong analytical skills with the ability to query, refine, and summarize data in a visual format.
• Excellent communication skills, with the ability to interact effectively across multiple functions (Customer Support, R&D, Manufacturing) and at various levels of the organization.
• Proven ability to work collaboratively within a team and independently as an individual contributor.
• Strong organizational skills, attention to detail, and ability to meet deadlines.
• Demonstrated ability to leverage and engage others to accomplish projects.

Responsibilities

• Own complaint investigation activities related to all Abbott Diabetes Care products, ensuring compliance with procedures and timely completion
• Partner with cross-functional Quality and Business Unit teams to deliver investigation results and implement impactful changes, including but not limited to
• Prepare and provide relevant reports and analysis in support of internal and external audits.
• Support company initiatives aligned with the Quality Management System (QMS) and other regulatory requirements.
• Ensure compliance with FDA and international regulatory requirements, and corporate/divisional policies, procedures, and processes.
• Perform additional related duties and responsibilities as assigned.

Benefits

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees